Kornimate/medical-research-clean huggingface dataset:
kineflex|c artificial disc system to treat cervical degenerative disc disease (ddd)

Conditions: Degenerative Disc Disease (DDD)

Summary: the purpose of this study is to show that the kineflex\|c spinal system is no worse than conventional anterior cervical diskectomy with fusion (acdf) in patients with single level degenerative disc disease at any cervical level from c3 to c7.

the kineflex\|c disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (ccm) end-plates and a fully articulating ccm core. the system is available in two foot print sizes.

Eligibility criteria:
inclusion criteria: * have symptoms of cervical degenerative disc disease (ddd) at only one cervical level from c3 to c7, disc herniation on ct or mri; * have radiculopathy symptoms in neck, one or both shoulders, and/or one or both arms; * have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose), the presence of progressive symptoms (e.g., increasing numbness or tingling), or signs of nerve root compression; * have moderate disability neck disability index (ndi) score; and * be likely to return for all follow-up visits and be willing and able to provide informed consent for study participation exclusion criteria: * marked cervical instability; * non discogenic neck pain or non discogenic source of symptoms; * radiographic confirmation of severe facet disease or facet degeneration; * bridging osteophytes; * prior surgery at the level to be treated; * prior fusion at any cervical level; * more than one neck surgery via anterior approach; * previous trauma to the c3-c7 levels resulting in compression or bursting; * documented presence of free nuclear fragment at any cervical level; * severe myelopathy; * any paralysis; * history of chemical or alcohol dependence; * active systemic infection; * infection at the site of surgery; * prior disc space infection or osteomyelitis in the cervical spine; * any terminal, systemic or autoimmune disease; * metabolic bone disease (e.g., osteoporosis, gout, osteomalacia, paget's disease); * any disease, condition or surgery which might impair healing; * known metal allergy; * arachnoiditis; * currently experiencing an episode of major mental illness; * pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery; * morbid obesity; use of spinal stimulator at any cervical level prior to surgery; * currently a prisoner; * currently involved in spinal litigation which may influence the subjects reporting of symptoms; or * lives more than 300 miles from study center or participation in any other investigational drug, biologic, or medical device study within the last 30 days prior to study surgery

Keywords: ddd artificial disc
investigating the use of fluorescent lectins to identify dysplasia and cancer during endoscopy and surgery

Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Polyp

Summary: this is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above * participants undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy or transanal endoscopic microsurgery (tems), including robotic assisted tems * in the investigator's opinion, is able and willing to comply with all study requirements exclusion criteria * participant who is unable to unwilling to give informed consent * female participant who is pregnant, lactating or planning pregnancy during the course of the trial. if there is an uncertainty regarding whether a woman could be pregnant, then they will be excluded from the study * participants with known egg allergies, ovalbumin allergy and soya allergies

Keywords: colonoscopy fluorescence guided surgery
a study of cm383 in patients with alzheimer's disease related mild cognitive impairment and mild alzheimer's disease

Conditions: Alzheimer Disease

Summary: this is a randomized, double-blind, placebo-controlled and multiple dose escalation phase ib study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of cm383 in patients with alzheimer's disease related mild cognitive impairment and mild alzheimer's disease.


Eligibility criteria:
inclusion criteria: * voluntarily participate and have the subject and their legal guardian jointly sign the informed consent form. * the age of the subjects is between 50 and 85 years old. * bmi≥19kg/m2 and ≤32.5 kg/m2, weight ≥45 kg and ≤100 kg at screening or baseline. exclusion criteria: * cognitive impairment of subjects due to other medical or neurological factors (other than ad) * history of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year * with any mental illness that may interfere with the cognitive assessment of the subjects. * with history of moderate or severe renal dysfunction. * with uncontrolled stable hypertension. * with history of severe trauma or major surgery in the 6 months prior to the screening period, or planned surgery during the study. * history of malignancy within 5 years prior to screening.
scarring at donor sites after split-thickness skin graft.

Conditions: Donor Site Complication

Summary: the aim of this study was to investigate if previous findings on the association between dressing treatments and subjective opinion on final donor site scar outcome using the patient scale of posas could be confirmed objectively. scar outcome measurements were assessed by a blinded observer using posas and the device: cutometer dual mpa 580 (courage and khazaka electronic gmbh, cologne, germany) to measure the viscoelasticity of the skin.

this is the third and last part of a clinical project concerning the treatment of split thickness skin graft donor sites. in the first part the investigators completed a randomised clinical trial (rct) in which donor sites were randomly assigned to treatment with either hydrofibre covered with film, non-adhesive polyurethane foam, or porcine xenograft. results from the first study indicated that donor sites treated with hydrofibre and porcine xenograft healed significantly faster than those treated with polyurethane foam. as the hydrofibre was the most comfortable, easy to use, and cost-effective it was implemented as the standard of care for donor sites at the specific centre. in the initial rct, patients treated with polyurethane foam showed significantly longer healing times than the other treatment groups. as longer healing time has been shown to be a predictor for pathological donor site scarring it was hypothesised that this group would be the most unsatisfied with their scars, if they had any donor site scar at all eight years after their skin graft. in the second part of the project the long-term scar outcomes of the donor sites included in the rct was investigated. study participants were asked to evaluate their scars using the "patients part" of the patient and observer scar scale (posas). after analysing the data collected in the second part, it was concluded that the fast and moist healing seen with hydrofibre seemed to result in significantly more satisfied patients - and members of the polyurethane foam group, as hypothesised, were significantly more unsatisfied with their donor site scars. the investigators also found that the dressing associated with the fastest wound healing (the porcine xenograft) also had the poorest long-term outcome for scarring, according to the patients' opinion. this contradicts what is claimed to be the relation between duration of healing and donor site scarring. in this last, third study, the aim was to investigate if the previous findings could be confirmed by an evaluation done by a blinded observer using posas. donor sites were also evaluated for firmness and elasticity using the device; cutometer dual mpa 580 (courage and khazaka electronic gmbh, cologne, germany), which is described in the method section.

Eligibility criteria:
inclusion criteria: participation in part i (rct) and part ii of the project exclusion criteria: no former participation in the project
kul0401: an open-label pilot study of oxatomide in steroid-naive duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne

Summary: this study will help to determine the safety and efficacy of the mast cell stabilizer oxatomide as a treatment for duchenne muscular dystrophy (dmd). boys with dmd who are enrolled in this study will should not have taken steroids to treat dmd for at least twelve months, and should not have taken any nutritional supplements for at least three months. subjects will complete a two screening visits within a one-week period, and if enrolled will then have their strength tested monthly for three months before beginning therapy with oxatomide. once oxatomide therapy is started, participants will have their strength tested monthly for six months. following the six month treatment period, participants will be given the option to remain on oxatomide until the study is completed.


Eligibility criteria:
subject inclusion criteria 1. 5 to 10 years of age 2. ambulatory 3. diagnosis of dmd confirmed by at least one of the following: * positive x-linked family history of dmd in older male relatives (onset by 5 years, wheelchair bound by 12 years), or; * dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical dmd, or; * gene deletion test positive (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as 'out of frame', and clinical picture consistent with typical dmd. 4. glucocorticosteroid-naive (i.e. has not been treated with prednisone or deflazacort within the past year) 5. evidence of muscle weakness by mrc score or clinical functional evaluation 6. qmt biceps score variability no greater than 10% between screening visits subject exclusion criteria 1. failure to achieve one or more of the inclusion criteria listed above 2. inability to suitably cooperate with strength assessments 3. symptomatic dmd carrier 4. use of oxatomide (or other anti-histamine drugs) within the last 6 months for dmd or any other disease 5. use of creatine monohydrate or glutamine within the last 6 months 6. use of carnitine, coenzyme q10, other amino acids or any herbal medications within the last 3 months 7. history of symptomatic cardiomyopathy 8. history of impairment of hepatic function 9. history of significant concomitant illness or significant impairment of renal function.

Keywords: duchenne muscular dystrophy controlled clinical trial cinrg
pocd in elderly patients following desflurane or sevoflurane general anesthesia

Conditions: 1. Postoperative Cognitive Dysfunction

Summary: the use of desflurane in elderly subjects (\>65 years old) undergoing general anesthesia with endotracheal intubation will result in decreased pocd compared to sevoflurane if the patient's map is within 20% of the patient's baseline and the cerebral suppression state index stays within the moderately anesthetized range during general anesthesia.


Eligibility criteria:
inclusion criteria: * adult patients (\>65 years old) * scheduled for elective surgery requiring general anesthesia at llumc hsh * airway management expected to include endotracheal intubation * expected surgical duration 120 to 240 minutes exclusion criteria: * pre-existing significant psychiatric disease or mental status changes * clinically significant cardiovascular, respiratory, hepatic, renal,neurological, psychiatric, or metabolic disease * patient's weighing \>50% ideal body weight * men: ideal body weight (in kilograms) = 50 + 2.3 kg per inch over 5 feet * women: ideal body weight (in kilograms) = 45.5 + 2.3kg per inch over 5 feet * patients who have undergone a general anesthetic within the past 7 days * patient refusal

Keywords: problems with thinking after surgery;
ascvd management using ccta in prostate cancer patients on adt

Conditions: Prostate Cancer

Summary: this is a randomized pilot study of coronary ct angiography (ccta) for coronary atherosclerosis vs. usual care in patients with prostate cancer who are either planning to begin, or are currently taking androgen deprivation therapy (adt) .

this is a randomized pilot study where subjects are randomized 1:1 to either the ccta group or non-ccta (usual care) group. the target enrollment will be 100 subjects with accounting for a potential 10% dropout rate resulting in an sample size between 90-100 participants or 45-50per group arm.

Eligibility criteria:
inclusion criteria: 1. written informed consent and hipaa authorization for release of personal health information 2. age ≥40 years at time of consent 3. previous diagnosis of prostate cancer who are either currently receiving adt, or who are planning to start adt for \>12 months 4. patients currently on or planned for treatment with adt plus androgen pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) are allowed 5. ≥1 risk factor for ascvd (hypertension, hyperlipidemia, diabetes, tobacco use) 6. no current cardiac symptoms exclusion criteria: 1. concurrent treatment with chemotherapy (docetaxel, cabazitaxel, mitoxantrone) at time of signing consent 2. patient has implantable cardioverter-defibrillator (icd), or pacemaker 3. history of coronary stents, obstructive coronary artery disease, myocardial infarction, coronary artery bypass grafting. history of atrial fibrillation 4. renal dysfunction with creatinine clearance \<35ml/min (calculated by cockcroft-gault equation) 5. allergy to iodinated contrast 6. contraindication to the medications that may be given to regulate heart rate for the ccta scan (applicable only to those randomized to the ccta group) 7. patients taking sildenafil or tadalafil for vasodilation, pulmonary hypertension, or bph 1. note: subjects taking sildenafil or tadalafil for erectile disfunction will still be eligible.

Keywords: prostate cancer coronary atherosclerosis quantitative coronary ct angiography androgen deprivation therapy
acupuncture for ischemic post-stroke depression

Conditions: Post-stroke Depression

Summary: this is a multicentre, single blind ,randomized controlled clinical trial in ischemic post-stroke depression patients.the participants will be allocated randomly in either of the two groups: verum acupuncture plus placebo medication group or sham acupuncture plus true medication group. on the hypothesis that acupuncture intervention could produce the same therapeutic effects as antidepressants. the investigators also hypothesized that acupuncture would be associated with minimal side effects.

aim: to observe the curative effect of acupuncture in the treatment of ischemic post-stroke depression． design: a multicentre,open-label randomized controlled trial will be performed in tianjin and beijing . two hundred and eight participants with ischemic post-stroke depression patients were randomly divided into two groups which were both given basic treatment of stroke. the acupuncture group was given tiaoshenkaiqiao acupuncture therapy and placebo，while the control group was treated with fluoxetine tablets and sham acupoint acupuncture treatment. evaluated the clinical efficacy of the two groups with hamilton depression scale(hamd), barthel index (bi),treatment emergent symptom scale,(tess ),clinical global impression scale(cgi) respectively before treatment, the second weekend of treatment ,the fourth weekend of treatment, the eighth weekend of treatment, the twelfth weekend of treatment. and observed the adverse reaction of the two groups. each participants will receive 36 sessions of acupuncture in 12 weeks, with a duration of 30 minutes in a session. after all the treatments were accomplished, there will be one follow-ups in the 24th week.

Eligibility criteria:
inclusion criteria: * in accordance with diagnosis of ischemic stroke in international classification of diseases-10 163, （icd-10 163）; * diagnosis of a major depressive episode according to the depression module of the structured clinical interview for the diagnostic and statistical manual of mental disorders-iv （dsm-iv）or chinese classification and diagnostic criteria of mental disorders-3(ccmd-3) * age of a subject is between 40 and 80 years old, male or female; * most recently experience an ischemic post-stroke depression and recent (\<6 months); * conscious, examination cooperation, without aphasia and severe cognitive impairment; * capacity to provide written consent for both research assessment and treatment. exclusion criteria: * participation in any clinical trial within the previous or taking antidepressant treatment 2 weeks prior to baseline; * presence of severe cognitive dysfunction, indicated the mini-mental state examination (mmse) score of \< 17 * presence of severe aphasia; * had a history of psychiatric illness or depression * impaired hepatic , renal function., hematological systems and so on; * those who can not cooperate with treatment; * pregnant women or women in lactation * presence of another chronic disorder, including chronic alcoholism or durg abuse

Keywords: post-stroke depression acupunture fluoxetine rct
additional effects of transversus abdominial strengthening along with pelvic floor muscle strengthening on stress urinary incontinence among multiparous women

Conditions: Stress Urinary Incontinence

Summary: sui stands for stress urinary incontinence. a common condition seen among multiparous women associated with physical strain like bending, coughing, sneezing that put strain on the pelvic floor muscles.


Eligibility criteria:
inclusion criteria: * age group: multiparous women ( 30-50 yrs) * females only * all modes of delivery of childbirth * diagnosed cases of sui from fauji foundation hospital. * patient without any medical contraindications and limitations (sign and symptoms of sui) * accordances with the michigan incontinence index exclusion criteria: * pregnancy or recent childbirth * any history of pelvic organ prolapse or surgical intervention * metabolic diseases, uncontrolled hypertension as well as neurological intervention * any kind of malignancy in lower abdomen
the evaluation of a nasal mask for the treatment of obstructive sleep apnea

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Summary: this investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

a maximum of 12 osa participants who currently use a nasal mask will be recruited for the trial. participant will be on the trial for 1 night (in-lab)

Eligibility criteria:
inclusion criteria: * adult (18+ years of age) * able to give consent * apnea hypopnea index (ahi)≥ 5 on diagnostic night * prescribed pap for osa * existing nasal mask user exclusion criteria: * inability to give consent * patients who are in a coma or a decreased level of consciousness * anatomical or physiological conditions making automatic positive airway pressure (apap) therapy inappropriate (e.g. unconsolidated facial structure) * commercial drivers who are investigated by new zealand transport agency * current diagnosis of carbon dioxide (co2) retention * pregnant or may think they are pregnant
invest-cto pci trial

Conditions: Chronic Total Occlusion of Coronary Artery; Angina Pectoris; Quality of Life; PROM

Summary: following unsuccessful cto crossing a cto modification procedure is sometimes performed. cto pci registries where plaque modification has been performed in some patients, report this to be safe, and associated with higher success rates at subsequent attempts. it has never been investigated whether a planned investment procedure, with an intention that both the initial and staged completion pci are of shorter duration, could improve safety and efficacy. the investigators hypothesize that 1. a planned investment procedure in the treatment of ctos will be associated with improved patient safety 2. a planned investment procedure will be associated with improved cumulative procedure success rates 3. a planned two stage procedure will be associated with improved patient experience


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent * comply with the procedural and study follow-up schedule * planned cto pci in accordance with the european and american appropriateness criteria. * cto defined as high-risk exclusion criteria: * non-high risk cto * occlusion within a stent * flush aorto-ostial occlusion of rca and left main (lms) * limited arterial access precluding repeat procedure * baseline non invasive testing showing non-viable target vessel territory * contra-indication to dual antiplatelet therapy * pregnancy * prior radiation skin injury * lack of informed consent

Keywords: percutaneous coronary intervention
clinical evaluation of a new highly sensitive thyroglobulin assay in differentiated thyroid carcinoma

Conditions: Thyroid Neoplasms

Summary: human thyroglobulin (tg) is the most sensitive biochemical marker for recurrence of differentiated cancer (dtc), especially after the complete removal of thyroid tissue through surgery and radioiodine therapy (rit). unfortunately, current assays for measuring tg in blood samples are not sensitive enough to reliably measure tg while patients are under thyroid hormone replacement therapy. instead patients have to withdraw thyroid hormone for several weeks or receive costly injections of recombinant thyroid stimulating hormone (tsh) in order to raise tg production by thyroid remnant and/or thyroid cancer cells so that it can be measured by current tg assays. other patients have antibodies against tg that interfere in current immunoassays. the purpose of the study was to characterize a new highly sensitive assay for measuring tg in the serum in thyroid cancer patients both on thyroid hormone therapy and off therapy in comparison to the normal routine assay already in use at münster university hospital.

sera of 100 consecutive dtc patients after total thyroidectomy were to be collected at the department of nuclear medicine both under tsh-suppression therapy and under endogenous tsh stimulation (tsh \> 25 mu/l). all patients were staged by clinical examination, cervical ultrasound (7.5 mhz), i-131 whole-body scintigraphy and - where applicable - f18-fdg-pet. written informed consent was obtained from all pts. sera were taken in separation tubes without anticoagulants and stored at -20°c until analysis. sera were allowed to come to room temperature prior to analysis. tg, tgr and tgab concentrations were determined by fully automated two-site chemiluminescence immunoassays (clia; nichols advantage®; nichols institute diagnostics, san clemente, california). all 3 assays are based on the identical highly purified htg material for calibration (tg), recovery (tgr) and antigen (tgab; biotinylated and acridinium ester labeled) for optimum comparability of test results. in addition, tg and tgr was measured by a fully automated two-site trace immunoassay (brahms kryptor®, brahms ag, hennigsdorf, germany) and tsh with a 3rd-generation clia assay (tsh-3, advia centaur, bayer corporation).

Eligibility criteria:
inclusion criteria: * histological diagnosis of differentiated thyroid carcinoma * total or near total thyroidectomy * informed consent exclusion criteria: * no informed consent

Keywords: differentiated thyroid carcinoma thyroglobulin immunoassay thyroidectomy radioiodine therapy